The Subcommittee on Workforce Protections House Education and the Workforce Committee

 Speaker:

Jeffress, Charles N.

 Status:

Archived

NOTICE: This is an OSHA Archive Document, and may no longer represent OSHA Policy. It is presented here as historical content, for research and review purposes only.

STATEMENT OF CHARLES N. JEFFRESS
ASSISTANT SECRETARY
OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION
U.S. DEPARTMENT OF LABOR
BEFORE
THE SUBCOMMITTEE ON WORKFORCE PROTECTIONS
HOUSE EDUCATION AND THE WORKFORCE COMMITTEE

JUNE 22, 2000

Mr. Chairman, Members of the Subcommittee, thank you for inviting me to testify about the
Occupational Safety and Health Administration's (OSHA's) revised bloodborne pathogens
compliance directive. I am pleased to have this opportunity to explain the directive and to talk
about what OSHA is doing to eliminate or minimize the risk of needlesticks and other sharps
injuries, and to tell what we learned from our Request for Information (RFI) on the current use of engineering and work practice controls in the workplace.

Bloodborne Pathogens are a Serious Hazard

OSHA published the final bloodborne pathogens standard in 1991 in response to the significant
health risk associated with occupational exposure to blood and other potentially infectious
materials. At that time, nearly six million workers in health care and related occupations faced
exposure to bloodborne diseases. The standard applies to employees who have occupational
exposure to the hazard, the presence of blood or other potentially infectious materials, whether or not a needlestick injury has occurred at the worksite. Diseases caused by bloodborne pathogens include, but are not limited to: Hepatitis B (from the Hepatitis B virus (HBV)); Hepatitis C (from the Hepatitis C virus (HCV)); acquired immunodeficiency syndrome (AIDS) (from the human immunodeficiency virus (HIV)); HTLV-I-associated myelopathy (from the human T-lymphotrophic virus Type 1 (HTLV-I)); diseases associated with HTLV-II; and malaria, syphilis, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, Creutzfeldt-Jakob (known as mad-cow) disease, and viral hemorrhagic fever. Many of these diseases are fatal, and at the time the standard was issued, OSHA predicted that each year the standard would prevent 5,058 - 5,781 occupational HBV infections and 113-129 Hepatitis B deaths.

The standard has been an enormous success. Since the standard was promulgated in 1991, the
rate of occupationally acquired Hepatitis B infection has declined dramatically. I believe OSHA's
standard, among other factors, contributed to the decline -- in particular the standard's
requirement that employers provide and pay for Hepatitis B vaccines for employees exposed to
blood or other potentially infectious materials. In 1987, there were 8,700 cases of Hepatitis B
infection among health care workers. In 1995, just four years after publication of OSHA's
standard, only 800 new cases related to occupational exposure were reported by the Centers for
Disease Control and Prevention (CDC).

Despite the standard's success in addressing HBV, OSHA always has been and continues to be,
concerned about injuries from needles and other sharps that are contaminated with blood or other
potentially infectious materials, particularly in health care settings where employees are frequently exposed to needles and sharp instruments. Notably, needlesticks alone account for up to 80% of the occupational exposures to blood (Jagger, J. "Rates of needlestick injury caused by various devices in a university hospital." New England Journal of Medicine. 319(5): 284-8; 1988). The health research community estimates 600,000 to 800,000 needlestick injuries occur annually -- on average that is one incident a year for every seven health care workers. According to the CDC, about half of needlestick injuries go unreported. CDC has stated that an average hospital incurs approximately 30 worker needlestick injuries per 100 beds per year. Most reported needlestick injuries involve nursing staff. However, CDC indicates that laboratory staff, physicians, housekeepers, dental assistants, and other health care workers have also experienced needlestick injuries -- and are still being injured. (National Institute of Occupational Safety and Health (NIOSH) Alert, "Preventing Needlestick Injuries in Health Care Settings" (CDC, 1999)). Because such injuries continue to be the primary source of occupational exposure to bloodborne pathogens, OSHA and other public health agencies are stressing the importance of reducing these risks.

Between 1985 and December 1999, the CDC reported 56 documented cases of occupationally
acquired HIV infections in health care workers and an additional 136 cases of possible
occupational HIV transmissions. The risk of contracting Hepatitis C, for which there also is no
vaccine, and no cure, is far greater.

Before proceeding to discuss the risk faced by health care workers from HCV, I would like to
provide some background on this little-known disease. HCV infection often occurs with no
symptoms, or only mild symptoms. But, according to the CDC, "chronic infection develops in
75% to 85% of patients, with active liver disease developing in 70%. Of the patients with active liver disease, 10% to 20% develop cirrhosis, and 1% to 5% develop liver cancer." (NIOSH Alert, "Preventing Needlestick Injuries in Health Care Settings"). Population-based studies indicate that 40% of chronic liver disease is HCV-related, resulting in an estimated 8,000-10,000 deaths each year. In addition, HCV-associated end-stage liver disease is the most frequent indication for liver transplantation among adults (MMWR October 16, 1998, Vol. 47 (RR19);1-39).

A health care worker's risk of exposure to HCV is much higher than the risk of exposure to HIV.
The risk is increased in part because the frequency of HCV in the population far outstrips the
frequency of HIV. According to the CDC, 3.9 million Americans have been infected with HCV
(MMWR October 16, 1998, 1-39). In comparison, the number of people living with HIV is
estimated to be between 650,000 and 900,000 (CDC Update, "How Many People Have HIV &
AIDS," May 1999). Because more Americans have HCV than HIV, health care workers face a
greater risk of encountering a patient with HCV than a patient with HIV. Of the total acute
Hepatitis C infections that occurred in 1995, the CDC estimates that 2%-4%, or 720-1400, were in health care workers exposed to blood in the workplace. (MMWR October 16, 1998, 1-39).
Although we do not know how many of these cases are attributable to needlesticks or others
sharps injuries, we do know that the transmission rate for HCV percutaneous injuries is higher
than that for HIV: the CDC estimates an average transmission rate of 0.3% per injury for HIV, as compared to an average transmission rate of 1.8% for HCV. Both this higher transmission rate, and the higher frequency of HCV occurrence in the general population, lead to the conclusion that health care workers face a significant threat from HCV through needlestick and sharps injuries.

The Standard (29 CFR 1910.1030)

The bloodborne pathogens standard contains provisions which were designed and written to be
performance-oriented. In other words, the goals of the standard are clearly stated, yet many
aspects of the rule give employers considerable flexibility in choosing the methods most feasible
for accomplishing those goals. Thus, the standard directs employers to use engineering controls
and work practices to eliminate or minimize employee exposure to bloodborne pathogens, but it
does not list or specify particular engineering controls (such as which medical devices) that
employers must use. This approach allows the rule to take into account the continual progress of
medical research and technology and the diversity of workplaces and workplace operations and
processes, and allows the employer to determine what engineering controls will provide the best
protection.

A central provision of the bloodborne pathogens standard clearly demonstrates its flexible,
performance-oriented nature: paragraph (c) of 29 CFR Part 1910.1030 requires employers to
develop a written exposure control plan (ECP) that addresses, among other things, the site-specific engineering, work practice, and administrative controls the employer will use to prevent exposure to bloodborne pathogens for workers who have an ongoing occupational risk. In other words, the employer creates a plan that is tailored to the conditions of that employer's work place. The ECP must also include the procedures for evaluating circumstances surrounding an
exposure incident. The ECP is used to identify exposed or potentially exposed workers, i.e.,
those who need training, personal protective equipment, access to vaccinations, and treatment if
an exposure incident occurs.

OSHA believes the key to preventing needlesticks and other sharps injuries lies in a
comprehensive strategy - a programmatic approach through which employers: 1) use the ECP to
evaluate the hazards at their specific facility, 2) provide appropriate employee training for the safe and effective use of new equipment, and 3) evaluate the results and make changes accordingly. OSHA has found this strategy to be more successful when employees are involved in the safer device selection process. This overall approach is highlighted in the current compliance directive, which I will discuss in a moment.

OSHA is Addressing the Continuing Risk

Notwithstanding the success of the standard, OSHA recognizes a need to emphasize specifically
the continuing problem of needlesticks and other sharps injuries. Prior to OSHA's decision to
revise the bloodborne pathogens standard compliance directive, the agency received suggestions
to implement an emergency temporary standard mandating the use of safer devices, and to reopen
the bloodborne pathogens standard. Additionally, OSHA is currently considering, as
recommended by the Senate Appropriations Committee, a revision to the recordkeeping rule to
require that all exposure incidents resulting from contaminated needles and other sharps be
recorded on OSHA injuries and illnesses logs. Of course, any new rule would be drafted with
strong privacy and security safeguards. We are also aware of other Congressional interest in this area. Last year Senator Barbara Boxer and Representatives Pete Stark and Marge Roukema
introduced legislation entitled the "Health Care Worker Needlestick Prevention Act" (S.
1140/H.R. 1899). The Department of Labor expressed support for the intent of the bills in
October 1999 letters from Secretary Alexis Herman to Chairman Jim Jeffords, Senator Boxer, and
Representative Stark.

The Request for Information (RFI)

Since the promulgation of the bloodborne pathogens standard, the agency, along with the medical
and scientific community, has been aware of the continuing problem of needlesticks and other
sharps injuries. However, concrete data on the penetration, acceptance and effectiveness of
engineered sharps injury prevention devices were hard to collect, or even find. Therefore, in the Spring of 1998, OSHA began developing an RFI to gather information and data from the public.
OSHA was interested in learning which strategies for reducing injuries associated with
transmission of bloodborne pathogens were being successfully implemented in workplaces, and
we asked for ideas and recommendations on ways to better protect workers from contaminated
needles or other sharp instruments. The RFI solicited information on many aspects of
percutaneous (through the skin) injury prevention. Sixteen questions were carefully developed to
draw responses about the types of work settings where such injuries occur; percutaneous injury
surveillance; use, evaluation, and effectiveness of control methods; and economic factors
associated with the control of needlestick and other sharps injuries. The RFI was published in the FederalRegister on September 9, 1998, with a 90-day comment period. OSHA received 396 responses. More than 300 health care facilities provided comments, including nursing homes and clinics; acute care, and rehabilitation facilities, and pediatric hospitals. The Department of Veterans' Affairs, the largest health care provider in the Nation, submitted valuable information on its on-going needlestick prevention program. Several organizations submitted combined responses on behalf of members representing more than 130 additional health care facilities. Individual health care workers, researchers, unions, educational institutions, professional and industry associations, and manufacturers of medical devices also responded.

OSHA released a summary of the comments in May 1999. We learned three critical things from
the responses we received: 1) a variety of safer devices were already being used in a number of workplaces to protect workers from needlestick and sharps injuries; however, these devices were not being used widely enough to reduce the overall risk substantially; 2) training and education in the use of safer medical devices and safer work practices have proven effective in preventing exposures in these workplaces; and 3) employee involvement in the selection process can play an important role in the acceptance and proper use of safer medical devices.

"Safer devices" refers to the new technology that has been developing in the past several years to reduce the risk of needlesticks and other percutaneous injuries through elimination of the sharp or incorporation of safety features into a conventional sharp device (e.g. hypodermic syringe/needle). OSHA encourages employers to involve employees in the selection of effective engineering controls to improve employee acceptance of the newer devices and to improve the quality of the selection process. Examples of this technology include needleless devices, shielded needle devices, self-sheathing needles, self-blunting needles, and plastic capillary tubes. There are hundreds of these devices on the market, and this industry is constantly developing new devices. However the design quality and practical effectiveness of the devices in reducing injuries vary considerably.

The November 5, 1999, Compliance Directive

Compliance directives guide OSHA's compliance officers in enforcing standards by providing
instruction and ensuring that consistent inspection procedures are followed. OSHA recognizes
that employers and other members of the public have an interest in the guidance OSHA provides
to its compliance staff, and therefore we make such guidance documents available to the public
and post them on our website.

OSHA used a thorough and considered review process to develop the revised directive for the
bloodborne pathogens standard. Our industrial hygienists, occupational health nurses,
occupational physicians, and public health specialists provided a wealth of professional expertise, including wide experience in hazard control. Additionally, OSHA's attorneys reviewed the directive for consistency with the bloodborne pathogens standard. OSHA also drew upon almost
400 responses to the RFI and information from experts at the CDC, the Food and Drug
Administration (FDA), and the Training for Development of Innovative Control Technology
Project (TDICT).

I want to emphasize that the current directive is a restatement, clarification and further
explanation of the requirements of the bloodborne pathogens standard. It does not amend the
standard or create new legal duties, obligations or defenses. But while the standard has not
changed, control technology and medical treatment have. In the years since the standard was
promulgated, the ability to control exposure to, and transmission of, bloodborne pathogens has
improved significantly. These developments, along with what we learned from the RFI, provided
the impetus to update the compliance directive.

There are five main areas where additional instruction has been incorporated into the new
compliance directive. These areas include: an emphasis on the annual review of the ECP; a
clarification of how employers must evaluate and implement engineering controls; a description of
necessary employee training; new medical recommendations from the CDC; and, an explanation
of the applicability of the bloodborne pathogens standard in multi-employer worksites.

Exposure Control Plan [29 CFR 1910.1030 (c)]

Under the standard, employers must review and update their ECP at least annually, which ensures
that it remains current with the latest information and scientific knowledge concerning bloodborne pathogens. The ECP requires the employer to identify those tasks and procedures in which occupational exposure may occur, the individual workers who need to receive training, protective equipment, vaccinations and other protections of the standard, including the provision of engineering controls. In light of the increased use and acknowledged feasibility of safer medical devices, the ECP must document the employer's consideration and implementation of
appropriate, commercially available and effective engineering controls. The annual review and
update of the plan ensures that it, and the employer's efforts, reflect changes in technology, such as the use of effective engineering controls - safer medical devices - that can eliminate or minimize employee exposures at that workplace. The current CPL includes a sample "fill-in-the-blanks" exposure control plan as an appendix.

Under the standard, employers are required to institute engineering and work practice controls as
the primary means of eliminating or minimizing employee exposure. Employers must use
engineering and work practice controls that eliminate occupational exposure or that reduce it to
the lowest feasible extent. The CPL clarifies this intent by stating that "where engineering
controls will reduce employee exposure either by removing, eliminating or isolating the hazard,
they must be used." Through the mandatory exercise of the annual review of the ECP, employers are required to evaluate workplace exposures to bloodborne hazards and make changes to their ECP which include the consideration and implementation of new technology - safer medical
devices and safe work practices - where feasible. This requirement was stated in the preamble to the standard in 1991, and also reiterated in the 1992 compliance directive. Where implementation of engineering controls for a particular procedure are found to be infeasible, the employer should document this in the ECP and explain why no controls could be utilized. OSHA does not advocate the use of one particular device over another; however, in light of the increased use and acknowledged feasibility of safer technology, as demonstrated by the responses to OSHA's RFI, it is clear that some form of engineering control use will be feasible to prevent or minimize most workplace sharps exposures.

Training [29 CFR 1910.1030(g)(2)]

The CPL explains that the standard requires initial and annual refresher "interactive" training
sessions where employees must be able to ask questions of the person conducting the training,
and to receive immediate answers. This type of training may be supplemented with the use of
films or videos, as long as employees are provided an opportunity for discussion. Interactive
training is important to ensure that new devices are used correctly. Many of those who responded
to the RFI confirmed the need for effective and thorough training to achieve successful
implementation of safer medical devices.

New Medical Information

The standard [29 CFR 1910.1030 (f)(3)(iv)] requires employers to incorporate the medically
indicated recommendations of the U.S. Public Health Service (USPHS) for post-exposure
prophylaxis and follow-up. The CDC is the USPHS agency responsible for making these
recommendations. The CPL underscores the standard's requirement that employers use CDC
guidelines current at the time of the evaluation or procedure. The most recent CDC guidelines
included as appendices to the current CPL include: the December 26, 1997, "Immunization of
Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices
(ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC)" addressing
Hepatitis B; the May 15, 1998, "Public Health Service Guidelines for the Management of Health-Care Worker Exposures to HIV and Recommendations for Post-Exposure Prophylaxis;" and the
October 16, 1998, "Recommendations for Prevention and Control of Hepatitis C Virus (HCV)
Infection and HCV-Related Chronic Disease."

Multi-employer Worksites

The directive also includes instructions on inspection procedures for multi-employer worksites,
that are covered by the standard, which may involve, for example, employment agencies,
personnel services, home health services, independent contractors, and physicians in independent
practice.

Employer Assistance

In addition to the specific changes in the new directive, I would like to describe our outreach
efforts. Since the rule was promulgated, OSHA has made available to the public a large variety
of educational materials and technical information, as well as a great deal of guidance to assist
employers in complying with the bloodborne pathogens standard. For instance, OSHA has set up
a detailed "Technical Links" webpage that allows users to access multiple references from the
CDC, the FDA, and other recognized experts in this field such as the University of Virginia's
International Healthcare Worker Safety Center (responsible for EPINet, the Exposure Prevention
Information Network database) and TDICT. We have continued these efforts by including
several helpful resources in the appendices of the revised compliance directive: a list of the typical committees found in health care facilities; sample engineering control evaluation forms; a sample ECP; and an Internet resource list.

OSHA provides additional assistance through our ten Regional Bloodborne Pathogen
Coordinators - one located in each of OSHA's regional offices. The Coordinators may be
contacted on an individual basis whenever an employer, employee or OSHA staff person has
questions. In order to ensure OSHA's compliance personnel were aware of the new emphasis on
the importance of updating the ECP and the implementation of existing technology as required by
the engineering control sections of the standard, OSHA conducted an all-OSHA training session
in February of this year in Atlanta. Over 175 persons attended this training session. Attendees
included compliance officers from across the country, Regional Bloodborne Pathogens
Coordinators, State Plan personnel, and representatives from OSHA's Consultation programs. It
is important for OSHA's Consultation staff to know how OSHA enforces the rule, so that they
can share this information with affected employers. OSHA's Consultation program provides free
on-site assistance, and conducts numerous training and outreach programs for small employers.

Enforcement

In recent years, along with our outreach and education efforts to reduce needlesticks and other
sharps injuries, OSHA has begun to emphasize the enforcement of occupational health and safety
standards for health care workers, and in particular, enforcement of the bloodborne pathogens
standard.

OSHA identifies high hazard work sites for inspections through our annual Data Initiative, a
survey that collects lost workday injury and illness (LWDII) rate data from 80,000 establishments. When the Data Initiative first began, hospitals were not part of the surveyed population; therefore, no comprehensive inspections were scheduled in this sector. A small number of hospitals are being inspected this year under a pilot program involving data from the 1998 survey. This year's Data Initiative Survey, using 1999 data, includes 1,169 hospitals and we expect this to result in a higher number of comprehensive inspections.

Conclusion

We believe that implementation of the new compliance directive will provide our compliance
officers with the information they need to effectively enforce the bloodborne pathogens standard,
and raise employer awareness of, and compliance with, the standard. I am confident that
employers will find the new information in the revised compliance directive to be helpful. With
more than 600,000 needlesticks or other sharps injuries each year, OSHA, employers, and
employees must be proactive. It is in the country's best interest to care for the people who care for us. Ensuring that health care workers are protected from contracting deadly or debilitating diseases is the goal of our revised compliance directive.

NOTICE: This is an OSHA Archive Document, and may no longer represent OSHA Policy. It is presented here as historical content, for research and review purposes only.

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